Z-0475-2007

Howmedica Hip Fracture Stem System No. 3.5 Femoral Component Uses No. 3 Fenestrated Plus Sterile REF...

Name: Z-0475-2007 Howmedica Hip Fracture Stem System No. 3.5 Femoral Component Uses No. 3 Fenestrated Plus Sterile REF...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2006-11-28
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2006-11-28 / Terminated / root cause: packaging

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Howmedica Hip Fracture Stem System No. 3.5 Femoral Component Uses No. 3 Fenestrated Plus Sterile REF Catalogue #6942-0-035 Made in Ireland on 2006-11-28. The reason FDA records is "Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0475-2007
Status: Terminated
Initiated: 2006-11-28
Posted: 2007-01-13
Terminated: 2007-05-08
Recalling firm: Howmedica Osteonics Corp
Product: Howmedica Hip Fracture Stem System No. 3.5 Femoral Component Uses No. 3 Fenestrated Plus Sterile REF Catalogue #6942-0-035 Made in Ireland
Product code: KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Reason for recall: Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier.
Root cause tag: packaging
FDA root cause: Other
Action: Recall notification letters and product accountability forms were sent on 11/29 via Fed Ex with return receipt.
Quantity in commerce: 126 units
Distribution: Nationwide
Product codes and lots: Hip Fracture Stem # 3.5; Catalog number 6942-0-035; Lot codes: 7566701, 7819401, 7819402, 7819403, 7819405, 7869001, 7869002, 7869003, 7869004, 7869005, 7935701, 7935702, 7935704, 7999901, 7999902, 8152301, 8152302, 8152303, 8242501, 8850401, 8850402, 8850403, 8850404, 9503301, 9844801, 9844802, 9948201, 9948203, 10546201, 10546202, 10673501, 11090201, 11319301, 11319302, 11319303, 11369601, 11605702, 16033902, 16033903, 16165902, 16166001, 16840401, 16840402, 17289401, 17289402, 18448001, 18448002, 19131601, 10131602, 19490903, 19490904, 19834301.

Product code KWL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)